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Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer


Inclusion Criteria:



1. 18 years of age or older.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

3. Childs class of A or B (up to 9).

4. Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or
subject has HCC and refused surgery or subject is diagnosed hepatic metastases from
any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC).

5. Subject is voluntarily participating in the study and has signed the informed
consent.

Exclusion Criteria:

1. Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or
specific mixture of chemotherapy drugs to be used).

2. Evidence of severe or uncontrolled systemic diseases.

3. Congestive cardiac failure >NYHA class 2 MI within 6 months, active coronary artery
disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta
blockers or digoxin, unstable angina, or laboratory finding that in the view of the
investigator makes it undesirable for the patient to participate in the trial.

4. Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents
(that cannot be adequately mitigated with pre-procedure medication).

5. Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis
is acceptable.

6. Subject is breastfeeding.

7. Subject is pregnant

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Measuring Lipiodol deposition in tumor

Outcome Description:

Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging.

Outcome Time Frame:

Baseline to 6 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

J12115

NCT ID:

NCT01877187

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Liver Cancer
  • Primary liver cancer
  • Metastatic liver cancer
  • Liver Neoplasms

Name

Location

The Johns Hopkins HospitalBaltimore, Maryland  21205